(123 days)
Not Found
DePuy ORIF Small Fragment Plates,Synthes Small Plates,Synthes Small Titanium Plates
No
The summary describes standard orthopedic bone plates and screws for fracture fixation, with no mention of AI/ML capabilities or related data/performance metrics.
No.
The device is for internal fixation of bones (distal radius and proximal humerus) and does not deliver therapy.
No
The device description indicates it is a system of plates and screws for internal fixation of bones (distal radius and proximal humerus), which are used for treatment rather than diagnosis.
No
The device description clearly outlines physical bone plates and screws, which are hardware components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is designed for "internal fixation of the distal radius" and "internal fixation of the proximal humerus." This involves surgically implanting a device to stabilize bone fractures.
- Device Description: The device is described as "anatomically contoured bone plates which are attached to the bone with cortical or cancellous bone screws." This is a description of a surgical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used for structural support.
N/A
Intended Use / Indications for Use
The Distal Radius Plate System is designed for internal fixation of the distal radius. The distal radius plates are available in left and right volar configurations and in two sizes, small and large.
The Humerus Plate System is designed for internal fixation of the proximal humerus. The humerus plates are available in right and left configurations and in three hole and five hole length.
Cortical and cancellous bone screws are required to secure the plates to the bone. A variety of screw are available for this application in order to accommodate different fracture types and locations, bone density and surgeon preference.
Product codes
87HRS
Device Description
The ACE Humerus Plates and Radius Plates are anatomically contoured bone plates which are attached to the bone with cortical or cancellous bone screws. The humerus plates will offered in two configurations for both the left side and the right side. The plates are offered in three hole and five hole configurations.
The ACE Radius plates are also offered in a right and left configuration both for volar fixation and dorsal fixation. The plates are offered in a large and a small size.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Distal radius, Proximal humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ACE Humerus and Radius plates were tested in static bending and compared to the Synthes (USA) and the DePuy plates. Three types of plates (proximal humerus, volar distal radius and dorsal distal radius) were tested by applying static cantilever bending forces on the shaft/buttress interface of the plate. The ACE Plates were comparable in bending strength to the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DePuy ORIF Small Fragment Plates, Synthes Small Plates, Synthes Small Titanium Plates
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K955472
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ACE UPPER EXTREMITY PLATE SYSTEM
| Ace Medical Company |
|---|
| 2260 East El Segundo Blvd. |
| El Segundo, CA 90245 |
| Phone (310) 615-0066 |
APR
| Contact Person: | Nancy Giezen |
|---|---|
| Senior Regulatory Affairs Specialist | |
| Paul Doner | |
| Director, Regulatory/Clinical Affairs | |
| Proprietary Name: | ACE Humerus Plates |
| ACE Radius Plates | |
| Common Name: | Bone Plate |
| Classification Name: | Single / Multiple Component Metallic Bone Fixation Appliance and Accessories, 21 CFR 888.3030 |
| Proposed Regulatory Class: | Class II |
| Classification Panel: | Orthopaedic Device Panel |
| Device Product Code: | 87HRS Plate, Fixation, Bone |
Device Description:
The ACE Humerus Plates and Radius Plates are anatomically contoured bone plates which are attached to the bone with cortical or cancellous bone screws. The humerus plates will offered in two configurations for both the left side and the right side. The plates are offered in three hole and five hole configurations.
The ACE Radius plates are also offered in a right and left configuration both for volar fixation and dorsal fixation. The plates are offered in a large and a small size.
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ACE UPPER EXTREMITY PLATE SYSTEM
Intended Use:
The Distal Radius Plate System is designed for internal fixation of the distal radius. The distal radius plates are available in left and right volar configurations and in two sizes, small and large.
The Humerus Plate System is designed for internal fixation of the proximal humerus. The humerus plates are available in right and left configurations and in three hole and five hole length.
Cortical and cancellous bone screws are required to secure the plates to the bone. A variety of screw are available for this application in order to accommodate different fracture types and locations, bone density and surgeon preference.
Substantial Equivalence:
The ACE Humerus Plate and Radius Plate systems are considered substantially equivalent to the DePuy ORIF Small Fragment Plates and the Synthes Small Plates and Small Titanium Plates.
Performance Data:
The ACE Humerus and Radius plates were tested in static bending and compared to the Synthes (USA) and the DePuy plates. Three types of plates (proximal humerus, volar distal radius and dorsal distal radius) were tested by applying static cantilever bending forces on the shaft/buttress interface of the plate. The ACE Plates were comparable in bending strength to the predicate device
Safety and Effectiveness:
The upper extremity plates are manufactured of a biocompatable titanium alloy, commonly used in the orthopedic industry. The plates were shown to exhibit strength characteristics comparable to the predicate device. Thirdly, no new indications have been introduced with these devices. Therefore, the ACE upper extremity plates are considered to be a safe and effective means of fracture fixation.